MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number MZ9270

Device Problems Leak/Splash (1354); Separation Problem (4043)

Patient Problems Hypoglycemia (1912); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd maxzero multi-fuse extension set with needleless connector separated.The following information was received by the initial reporter with the following: date of occurrence: on (b)(6) 2024.Description of what happened: infant with low blood sugar reading <25.Ivf d10w infusing.Rn noted trifuse separated at the filter.Rn changed trifuse, blood sugar came up with bolus of d10w, product#: and lot#: mz9270, lot#: 22119145, was the course of treatment altered? neonate required bolus of d10w to bring blood sugar up.Any harm to the patient? mild temporary harm.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of separation at tubing to filter connection could not be verified due to the product not being returned for failure investigation.Device history record review for model mz9270, lot number 22119145 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

No additional information was provided.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18748335
• MDR Text Key: 335934563
• Report Number: 9616066-2024-00274
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MZ9270
• Device Lot Number: 22119145
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention